The invention relates to the technical sector of abdominal wall reinforcements or replacements, by extension addressing cases of muscle and aponeurosis loss.
More particularly, the invention concerns a prosthesis or prosthetic element for the treatment of vertical abdominal eventrations, and preferably median eventrations.
A vertical eventration or vertical median eventration occurs or can occur when the aponeuroses surrounding the rectus abdominis muscles are torn, for example, by trauma or failed suturing after open abdominal surgery, or when the muscular system spontaneously collapses. The internal pushing pressure generated by the intestines on the abdominal muscle wall is so great that the space created by the tear between the rectus muscles becomes filled with intestines enveloped in the peritoneum which spills outside the body.
U.S. Pat. No. 4,769,038 discloses a three-layered prosthesis with two opening sheets fastened to a third. The prosthesis, therefore, has the general appearance of a letter Y, rendering it unsuitable for the treatment of eventration.
Other prosthetic devices for body wall repair are known and described in patent WO 92/19162. The prosthetic device is shaped like a mushroom with a central cylinder fastened to two flat parts by a VELCRO-type system. This prosthetic unit is a plug preventing the orifice from skining over. Such a component is unsuitable for the treatment of vertical abdominal eventrations.
U.S. Pat. No. 5,254,133 to Seid discloses a prosthetic device for hernial repair, and in particular inguinal hernia repair. This type of device is commonly called a plug patch, and comprises two planar sheets of material or patches linked together by an elongated locating segment. The device can be folded or rolled up for insertion into a laparoscope and subsequently unrolled or unfolded at the site of the hernia.
The elongated locating segment makes this device, and hernial plug devices in general, unsuitable for the repair of eventrations because the extended length of the elongated locating segment between the two planar sheets prevents the muscles which have been separated by the eventration from being brought towards each other, the latter being a necessary condition for adequate eventration repair and for preventing a recurrence thereof.
Other plug devices are also known from U.S. Pat. 5,116,357 to Eberbach, and U.S. Pat. No. 5,147,374 to Fernandez. None of the prosthetic devices described in these patents is suitable for use in eventration repair, essentially for the reasons given above.
Accordingly, the purpose of the prosthetic device of this invention, principally designed for various types of eventration, is to reinforce the muscle wall tissue at the implant site, improving implant integration into the tissue while combining strength and resistance to deformation with great flexibility. In particular, the structure of the prosthetic device according to the invention is such that it enables a redistribution or resolution of abdominal pushing or thrust forces over a wide area. This capability reduces the risk of tearing of the device at the attachment sites of the prosthesis, and a slipping of the device leading to a recurrence of the eventration. Such a problem currently exists for the traditionally used single sheet of prosthetic material in eventration repair.
Another object of the invention is to provide a prosthetic device for repairing a torn aponeurosis between a first and second muscles.
It is a further object of the invention to provide a prosthetic device for eventration repair having a structure that enables a redistribution or resolution of abdominal pushing or thrust forces over a wide area.
A further object of the invention is to provide a prosthetic device for vertical median eventration repair which recreates a resistant and flexible prosthetic aponeurosis between the abdominis rectus muscles, and substantially recreates the linea alba.
Still yet another object of the invention is to provide a method of eventration repair using the prosthetic device according to the invention.
As stated previously, in order to enable a correct resolution of the abdominal pushing forces or thrust generated by the intestines, it is necessary to bring the rectus muscles and their aponeuroses towards each other. The applicant of present invention has solved this problem by providing a prosthetic device which enables excellent force distribution while at the same time providing a resistant repair zone to fill the space caused by the eventration and reconstitute the linea alba.